Pharmacovigilance 2019 is a course that addresses regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
Topics
- Risk Management and the development of the Pharmacovigilance plan
- Principles of Pharmacovigilance and Data Resources
- Pharmacoepidemiology Studies
- Causality Assessment: Clinical Diagnosis of Adverse Events
- Pro-active Pharmacovigilance Pre- and Post Marketing
- Evolution of PSURs, PBRERs and DSURs
- Risk/Benefit Analysis
- Pharmacovigilance Regulations (clinical trials & post marketing) including new EU Pharmacovigilance
- Post-marketing Surveillance: Observational Cohort Studios
- Drug Surveillance in countries outside Europe
- Introduction to Risk Management plans
- Introduction to Signal detection
- Practical Pharmacovigilance Workshop
Who should Attend
Those Working On Drug Safety Monitoring and concerned with pharmacovigilance In The EU, USA And Japan including: personnel in adverse reaction monitoring units, R&D departments, registration departments and regulatory affairs as wel as drug safety officers and pharmaceutical physicians.
